Abstract: 
The objective of the present study was to formulate mouth dissolving tablets of inclusion complex of tadalafil with improved aqueous solubility and dissolution rate. Tadalafil is a BCS class II drug having low aqueous solubility and therefore low oral bioavailability. In the present study, inclusion complex of tadalafil with hydroxypropyl-β-cyclodextrin were prepared by kneading method. Inclusion complex were characterized by differential scanning calorimetry (DSC), X-ray diffractometry (XRD), and ¹H NMR studies, and evaluated for in vitro dissolution, and phase solubility studies. DSC and XRD study demonstrated that there was a significant decrease in crystallinity of pure drug present in inclusion complex, which resulted in an increased dissolution rate of tadalafil and ¹H NMR studies strongly, confirmed that the inclusion complex has formed. Inclusion complexation results in improvement in solubility and dissolution rate have been used in preparation of mouth dissolving tablets using super disintegrants by direct compression method. A total of nine formulations were developed and the tablets prepared were evaluated for weight variation, friability, hardness and wetting time. In vitro disintegration and dissolution studies were also performed. On the basis of these results, mouth dissolving tablets of tadalafil- HPβCD inclusion complex may be considered as a promising alternative to conventional tablets with improved patient compliance.

Keywords: Hydroxypropyl Beta Cyclodextrin, Tadalafil, Mouth Dissolving Tablets, Dissolution.